NCT00143728暂停4 期
A Randomized Study to Evaluate Virologic Response Following Discontinuation vs. no Discontinuation of 3TC in Patients Who Are Infected With HIV With Previously Documented Reduced Susceptibility to 3TC and Who Have Adequate Virologic Suppression on Combination Antiretroviral Therapy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 入组人数
- 152
- 试验地点
- 9
- 主要终点
- Virologic failure (VL above 50 copies/ml) on two consecutive dates, at least two weeks apart, in the absence of concurrent acute illness or recent immunization during the first 24 weeks.
研究概览
简要总结
The purpose of this study is to compare the effects of continuing or discontinuing 3TC treatment in the presence of HIV virus with 3TC resistance for persons who are on a regimen including least three other anti-HIV drugs. The overall aim is to determine whether continuing 3TC is of benefit in HIV-positive persons who have already shown resistance to this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be HIV positive
- •Be at least 18 years old.
- •Currently receiving 3TC for HIV infection in conjunction with at least three other antiretroviral drugs. Must have started this regimen at least three months prior to starting this study.
- •A plasma viral load of less than 50 copies/mL on at least two occasions (measured at least 28 days apart immediately prior to screening).
- •Evidence of resistance to 3TC
排除标准
- •Pregnancy or breastfeeding.
- •Hepatitis B surface antigen (HbsAg) positive at time of screening or with the previous year.
结局指标
主要结局
Virologic failure (VL above 50 copies/ml) on two consecutive dates, at least two weeks apart, in the absence of concurrent acute illness or recent immunization during the first 24 weeks.
时间窗: 24 weeks
次要结局
- Percent and absolute change in viral load from baseline to week 24 and week 48.(48 weeks)
- Change in CD4 count in both absolute number and percentage from baseline to week 24 and week 48.(48 weeks)
研究者
研究点 (9)
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